AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354


codes

Device Classification Name

filter, blood, cardiopulmonary bypass, arterial line

510(k) Number K001138
Device Name AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
Original Applicant
MEDTRONIC VASCULAR
4633 e. la palma ave.
anaheim, 
CA 
92807

Original Contact marie holm
Regulation Number 870.4260
Classification Product Code
DTM  
Date Received 04/10/2000
Decision Date 04/27/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No